UMIN-CTR Clinical Trial

Public title

Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE

Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE-Mild cognitive impairment (ORANGE-MCI)

Acronym

ORANGE-MCI study

Scientific Title

Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE

Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE-Mild cognitive impairment (ORANGE-MCI)

Scientific Title:Acronym

ORANGE-MCI study

Region

Japan

Condition

Mild cognitive impairment, Dementia

Classification by specialty

Medicine in general	Neurology	Geriatrics
Psychiatry	Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The ORANGE programs are aimed at establishing an organized and dynamic registration system that collects time-based information based on age and disease stages (the ORANGE platform) by monitoring the entire clinical course of patients with dementia, including AD.

Basic objectives2

Others

Basic objectives -Others

The objective of the ORANGE-MCI program is to register patients with MCI (including early AD and other types of mild dementia), who comprise the core part of the ORANGE platform. Through registration of MCI patients, a dynamic registry will be established that can be updated and supplemented, where necessary, to collect longitudinal data. This program will be performed to establish an appropriate system for organized recording of clinical information to be collected (e.g., neuropsychological test results, brain image data, blood/cerebrospinal fluid samples), efficient patient registration, and data utilization.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The Kaplan-Meier method will be mainly used to determine parameters such as when a patient progressed to dementia from MCI or first had a CDR of 2 or more or an MMSE of 19 or less, in accordance with the statistical analysis plan.

Key secondary outcomes

Other analyses such as subgroup analyses will also be performed in accordance with the statistical analysis plan. Meanwhile, based on the advancement in statistical analysis methods, improvements and additions will be accordingly added to the current methods overall so that the most appropriate analysis will be constantly performed.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with MCI (including early AD and other types of mild dementia) aged 40 years or older who speak Japanese as their mother tongue. Patients must have a Clinical Dementia Rating (CDR) of 0.5-1 and a Mini-Mental State Examination (MMSE) score of 20-30.
2. Patients accompanied by a co-participant (study partner). The study partner must be physically and mentally healthy, contact the patient about once a week, and know how the patient lives. Preferably, the study partner should be able to make many visits together with the patient during the monitoring period.
3. Patients and their study partners are able to give written informed consent
4. No limitations on age, sex, or concomitant drugs
5. All types of MCI

Key exclusion criteria

1. Patients with a CDR of 2 or more or an MMSE score of 19 or less (including those with Alzheimer's disease, dementia with Lewy body, frontotemporal dementia, and vascular dementia). Those who meet this criterion will be eligible for another planned research protocol and are excluded from this program. Patients with the following conditions are also excluded: Parkinson's disease, apoplexy, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or decreased cognitive function due to head injury.
2. Any local lesion such as cerebral infarction(s) detected by CT or MRI before enrollment that can greatly affect the cognitive function
3. History of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; current serious or unstable disease
4. Patients unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, syphilis, or thyroid dysfunction
5. Inability to undergo CDR and MMSE tests
6. Patients deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution

Target sample size

1500

Name of lead principal investigator

1st name	Kenji
Middle name
Last name	Toba

Organization

National Center for Geriatrics and Gerontology

Division name

the former President of the National Center for Geriatrics and Gerontology

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511, Japan

TEL

0562-46-2311

Email

orange-registry@ncgg.go.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Sakurai

Organization

National Center for Geriatrics and Gerontology

Division name

Administrative Office of ORANGE Registry

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511, Japan

TEL

0562-46-2311(2390)

Homepage URL

http://www.ncgg.go.jp/orange/index.html

Email

orange-registry@ncgg.go.jp

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

National Center for Geriatrics and Gerontology and 37 hospitals in Japan

Name of secondary funder(s)

Organization

Research Promotion Office Research and Medical Division Planning and Management Department

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511, Japan

Tel

0562-46-2311

Email

yaday@ncgg.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立研究開発法人国立長寿医療研究センターと全国37施設

Date of disclosure of the study information

2016

Year

03

Month

01

Day

URL releasing protocol

http://www.ncgg.go.jp/orange/

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

11

Month

02

Day

Date of IRB

2018

Year

07

Month

17

Day

Anticipated trial start date

2016

Year

03

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The ORANGE-MCI program will provide a useful foundation for promoting many measures in accordance with the 7 pillars of the new ORANGE plan, including ''research and development of preventive care, diagnosis, treatment, rehabilitation models, and nursing care models, and the promotion of the resulting effects,'' as well as ''provision of appropriate and timely healthcare and nursing care according to the condition of dementia'' and ''support for caregivers of dementia patients.''

In order to stop the increasing prevalence of dementia, turn dementia into a curable disease, and slow the disease progress with nursing care, the data and stored samples should be open for access with close attention to the handling of personal information so that such information can be readily utilized in industry. The Japan Revitalization Strategy 2015 developed in June 2015 stipulates under the ''Construction of clinical innovation networks'' section that registered disease information should be utilized by corporations to promote clinical development. Since the organized registration system of the ORANGE-MCI program is intended to continuously register and monitor MCI patients, the system will be able to respond to requests from industry.

For further details, please see the clinical research protocol.

Registered date

2016

Year

03

Month

01

Day

Last modified on

2019

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024074